ISRCTN40182296进行中（未招募）Unknown
Paclitaxel or sirolimus coated balloons used for ArterioVEnous fistulas - 2 (PAVE-2 trial): a randomised controlled clinical trial to determine the efficacy of paclitaxel or sirolimus coated balloons in arteriovenous fistulas used for haemodialysis
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 642
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 14/05/2024:
- •1. Patients (18 years or over) who have a surgically formed AVF in the arm which has been used for at least 8 dialysis sessions in the preceding 4 weeks
- •2. An indication for a fistuloplasty as determined by the local clinical team
- •3. The access circuit is free of synthetic graft material or stents
- •4. Patient able to give informed consent
- •5. Patient willing and able to comply with all study-related procedures
- •6. People who are not breastfeeding, not pregnant, not intending to become pregnant or not intending to father children, within two years of study treatment
- •7. No evidence of active systemic or local (to the fistula) infection
- •8. No known hypersensitivity or contraindication to contrast medium which cannot be adequately premedicated
- •9. No known hypersensitivity or contraindication to paclitaxel or sirolimus
- •10. One or two treatment segments. Each treatment segment will contain one or more stenoses of at least 50%
- •11. Each treatment segment will be amenable to treatment with a single drug-coated balloon 8cm in length or two overlapping drug-coated balloons 4 cm in length
- •Previous inclusion criteria:
- •1. Patients (18 years or over) who have an AVF in the arm which has been used for at least 8 dialysis sessions in the preceding 4 weeks
- •2. An indication for a fistuloplasty as determined by the local clinical team
- •3. The access circuit is free of synthetic graft material or stents
- •4. Patient able to give informed consent
- •5. Patient willing and able to comply with all study-related procedures
- •6. People who are not breastfeeding, not pregnant, not intending to become pregnant or not intending to father children, within two years of study treatment
- •7. No evidence of active systemic or local (to the fistula) infection
- •8. No known hypersensitivity or contraindication to contrast medium which cannot be adequately premedicated
- •9. No known hypersensitivity or contraindication to paclitaxel or sirolimus
- •10. One or two treatment segments. Each treatment segment will contain one or more stenoses of at least 50%
- •11. Each treatment segment will be amenable to treatment with a single drug-coated balloon 8cm in length or two overlapping drug-coated balloons 4 cm in length
排除标准
- •1. Thrombosed (failed) access circuit at time of treatment
- •2. Location of a stenosis central to the thoracic inlet
- •3. The presence of a lesion that has been treated with a plain balloon fistuloplasty where the diameter of the outflow vein is larger than the size of the largest available drug-coated balloon
- •4. The presence of a lesion that has been treated with a plain balloon fistuloplasty where the diameter of the outflow vein is considered too small to be treated with the smallest available drug-coated balloon
- •5. A significant residual stenosis (more than 30%) at any treated lesion after plain balloon fistuloplasty
- •6. Lack of availability of any of the three types of treatment balloon (Medtronic IN.PACT, Concept Medical MagicTouch or control) at the required size
研究者
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